BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    MDR report key: 2022458 · Received February 15, 2011

    Report

    Report Number
    3015876-2011-00147
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    PHYSIO-CONTROL, INC.
    Product Code
    MKJ
    PMA / PMN Number
    K991910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PHYSIO-CONTROL EVALUATED THE DEVICE AND VERIFIED THE REPORTED FAILURE. THE SYSTEM AND MEMORY PCB ASSEMBLIES WERE REPLACED AND PROPER DEVICE OPERATION WAS OBSERVED THROUGH FUNCTIONAL AND PERFORMANCE TESTING. THE DEVICE WAS THEN RETURNED TO THE CUSTOMER FOR USE. PHYSIO FURTHER EVALUATED THE REMOVED ASSEMBLIES AND WAS ABLE TO VERIFY THE REPORTED FAILURE. IT WAS ALSO OBSERVED THAT THE REMOVED ASSEMBLIES WOULD CAUSE THE MOCK-UP DEVICE TO INTERMITTENTLY RESET AND FREEZE; HOWEVER, THE CAUSE OF THE REPORTED FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD ITS SERVICE INDICATOR ILLUMINATED; HOWEVER, UPON INITIAL EVAL, THE DEVICE WOULD LOCK UP WHEN POWERED ON. THERE WAS NO PT USE ASSOCIATED WITH THE REPORTED FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES MKJ PHYSIO-CONTROL, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA